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REVA MEDICAL announces the start of recruitment for the clinical trial of MOTIV IDE

San Diego, Oct. 1 /PRNewswire/ REVA Medical, LLC, a leader in absorbable polymer technologies for vascular applications, today announced that registration for the pivotal MOTIV study has begun at clinical centers in both the United States and Europe. The study will evaluate the use of a bioabsorbable MOTIV® sirolimus-eluting scaffold for the treatment of patients with chronic limb ischemia (CLTI). CLTI is an advanced stage of peripheral artery disease (PAD) that most commonly affects the arterial bed below the knee (BTK) and is associated with lower quality of life due to a higher risk of serious health problems, including amputations, negative cardiovascular disease, and mortality.

The MOTIV study is a global randomized controlled trial (RCT) designed to evaluate the safety and efficacy of the MOTIV scaffold for treating subperitoneal lesions in patients with CLTI by means of a randomized comparison with standard balloon angioplasty. The study led by Dr. Ehren Armstrong of Adventist Health in St. Helena, California and PD Dr. Medical Andrej Schmidt of Leipzig University Hospital will examine 292 patients at approximately 35 clinical centers in the USA and Europe.

“I am delighted to be part of this important study and to assess its potential to advance the science and treatments available for this highly complex patient population,” commented Jason Ricci, MD, of Bellin Health Cardiology Associates in Green Bay, Wisconsin, and physician who enrolled the first US patient.

MOTIV is a fully absorbable biocoated scaffold designed to degrade over time, freeing the artery from the permanent implant and allowing it to resume its normal, vascular motility. MOTIV is manufactured from REVA’s proprietary polymer, Tyrocore®, specifically designed for scaffolding performance. New Tyrocore properties provide increased scaffold strength in a thin strut design; It is designed to improve ease of use, including one-step inflation; It enables visualization of the entire device under fluoroscopy, a feature that makes MOTIV unique among bioabsorbable scaffolds.

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“We are committed to finding the best possible treatments to improve patient outcomes,” said Jeffrey Anderson, President and CEO of REVA Medical, LLC. “

The MOTIV scaffold has been approved in Europe since 2018, when the device became the first bioabsorbable scaffold to gain CE marking for below-knee use. PD Dr. Medical Schmidt recently recorded a live case using the MOTIV scaffold presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference 2022. During the procedure, PD Dr. Medical Schimdt implanted three MOTIV scaffolds 60 mm in diameter below the knee in a patient with CLTI. The patient showed positive results after surgery.

Henrik Schröder, MD, who enrolled the first European patients for the study at “Your Radiologies MVZ” in Berlin, said. “The scaffold was easy to spread and the procedure was facilitated by viewing the device under fluoroscopy, which is useful for confirming proper positioning.”

In August, REVA announced the closing of $45 million in Series B equity financing to support its MOTIV scaffold clinical program. This funding was led by Boston Scientific and existing investors.

For more information, visit the REVA website: www.revamedical.com

About REVA Medical

REVA Medical is a medical technology company focused on the development and commercialization of absorbable polymer technologies for vascular applications. The company’s products include MOTIV bioabsorbable scaffolds for the treatment of peripheral artery disease, Fantom and Fantom Encore vascular bioabsorbable scaffolds for the treatment of coronary artery disease and TyroSphere embolus granules. REVA is headquartered in San Diego, California. For more information, visit the REVA website: www.revamedical.com.

Fantom, Fantom Encore and MOTIV are CE marked only. Fantom, Fantom Encore, and MOTIV are available in select countries in Europe and the Middle East. Fantom, Fantom Encore, MOTIV, and TyroSphere are not available in the United States and other countries that do not accept the CE marking. Fantom, Fantom Encore, MOTIV, TyroSphere and Tyrocore are trademarks of REVA Medical, LLC.

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forward-looking statements

This announcement contains, or may contain, forward-looking statements that are based on management’s beliefs, assumptions, expectations and information currently available to management. All statements that are not historical facts, including statements regarding future operating plans or performance and events or developments that may occur in the future, are forward-looking statements, such as statements regarding expectations and timing in business operations, sales, clinical trials, pipeline product development and financing futuristic. No undue reliance should be placed on forward-looking statements. Although management believes that forward-looking statements are reasonable as of the date they are made, forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. Any forward-looking statements in this announcement speak only as of the date they are made. REVA undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

1 Duff S, Mafilios MS, Bounsule P, Hasegawa JT. The burden of critical limb ischemia: a review of the recent literature Vasc health risk management. 2019; 15: 187-208. doi: 10.2147/VHRM.S209241

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Questions and contact:

Jeffrey Anderson
informations@revamedical.com